New LVAD Testing in 10 U.S. Hospitals


November 21, 2007

November 21, 2007 - Ventracor announced 10 U.S. hospitals have implanted at least one VentrAssist left ventricular assist device (LVAD) as part of its U.S. clinical trials, as part of the company’s strategy to penetrate the U.S. VAD market.

The VentrAssist implantable blood pump is designed for long-term use, and the longest duration implant is now over three years. As part of the Company's US Bridge-to-Transplant (BTT) Pivotal Trial, which involves approximately 140 patients, 18 patients have been implanted in the U.S. The trial aims to evaluate the safety and efficacy of the VentrAssist for short-term use in patients whose heart deteriorates before a donor heart is available for transplant.

Eight patients have been enrolled in the US Destination Therapy (DT) Trial out of approximately 225 enrollments for the trial. The randomized trial is designed to evaluate the safety and efficacy of long-term use of the VentrAssist in patients with heart failure who are not candidates for a heart transplant. There have now been 172 implants at 24 hospitals worldwide, with over 83 years of cumulative patient experience.

The company has developed a new version, the VentrAssist LVA4, which will be introduced in all markets as soon as approval is obtained in response to the regulatory submissions already made.

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